Figure

3-1

 

The steps of the evaluation framework are interdependent,

 

99

Tables

3-1

 

Sources of Variability in Biomarker Measurements,

 

104

3-2

 

Information Needed for Package Inserts and Peer-Reviewed Publications Describing Biomarker Assays,

 

106

3-3

 

Utilization: Critical and Important Factors for Consideration (Recommendation 1c),

 

112

Chapter 4

Box

4-1

 

Conditions Associated with High Cardiac Troponins,

 

157

Figure

4-1

 

Inflammatory risk factors,

 

144

Tables

4-1

 

Brief Summary of the Results of the Case Studies,

 

132

4-2

 

Assays of Inflammatory Markers for Potential Clinical Use,

 

146

Chapter 5

Boxes

5-1

 

Expanding FDA Responsibilities,

 

201

5-2

 

Core FDA Regulatory Functions,

 

203

5-3

 

Dietary Supplements,

 

212

5-4

 

Role of NIH in Biomarker Data Collection,

 

224

Figures

5-1

 

Food and Drug Administration—Regulatory Industry (FY2006): The people, science, and information needed to support innovation, grow industries, and protect the public both in our country and around the world,

 

202

5-2

 

Comparison of Food and Drug Administration (FDA) health-related food label statements,

 

216

Table

5-1

 

Types of Claims,

 

210



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